相关临床试验
44
4 进行中
药物批准
5
批准总数
监管机构
1
监管机构数
成立时间
1890
已完成
38
86.4%
尚未招募
4
9.1%
招募中
1
2.3%
撤回
1
2.3%
- The World Health Organization has granted Phase II pre-qualification to Biological E Limited's Novel Oral Polio Vaccine type 2, enabling complete end-to-end manufacturing at a single integrated facility. - This milestone expands beyond the company's June 2024 Phase I qualification and allows for more resilient global vaccine supply for outbreak control efforts. - Biological E has already manufactured and supplied 700 million doses of nOPV2 to the global stockpile, with the vaccine deployed in over a billion doses worldwide. - The enhanced manufacturing capability strengthens global polio outbreak response readiness by providing continuous, flexible vaccine supply for controlling circulating vaccine-derived poliovirus type 2 outbreaks.
- BioNet and PT Bio Farma have signed a strategic MoU to develop and distribute a combined TdaP vaccine targeting tetanus, diphtheria, and acellular recombinant pertussis across ASEAN markets. - The partnership aims to reduce vaccine introduction timelines from 10-15 years to less than five years through combined clinical development and regulatory alignment strategies. - The collaboration targets an estimated 10-15 million doses annually in the ASEAN market, valued at approximately USD 200 million, focusing on adolescents, pregnant women, and elderly populations. - Bio Farma will lead clinical trials and regulatory submissions in Indonesia while BioNet handles other ASEAN countries, leveraging each company's regional expertise and manufacturing capabilities.
